Kornimate/medical-research-clean huggingface dataset:
the rovo study: radial optic neurotomy for cvo

Conditions: Central Retinal Vein Occlusion

Summary: the rovo study is a prospective, placebocontrolled and randomised study designed to evaluate the effect of radial optic neurotomy in central vein occlusion, versus triamcinolone acetonide. 240 patients with a visual acuity \< 0.5 snellen will be randomised. patients are treated with either ron, or a single intravitreal injection of 4 mg triamcinolone acetonide, or a placebo treatment - a "sham" injection of intravitreal triamcinolone. patients will be examined regularly over a period of one year. best corrected visual acuity for far and near, as well as clinical examinations, fluorescein- and indocyanine green angiograms, optical coherence tomography, and perimetry, are performed pre- and postoperatively.


Eligibility criteria:
inclusion criteria: * onset of cvo not longer than 12 months * on fla 1. nonperfused - (greater than 10 disc area of nonperfusion) 2. perfused - visual acuity lower than 0.1 snellen,or 3. perfused with no improvement of visual acuity over 4 weeks) exclusion criteria: * • dense cataract\* (grade 3 and 4) which precludes judgement of the fundus. * pregnancy * allergy against fluoresceine or indocyanine green * unable to come for follow up visit * presence of other severe retinopathy or * presence of advanced optic atrophy or uncontrolled glaucoma. * visual acuity higher than 0.5 snellen.
developing optimal focal muscle vibration for improving spasticity

Conditions: Vibration; Electrophysiology; Muscle Spasticity

Summary: the overall aim of the proposed study is to determine optimal parameter of focal muscle vibration for improving spasticity and identify neurophysiological mechanism in healthy subjects. in investigation i-1, subjects will undergo focal muscle vibration with 40, 80, 120 hz frequency at the medial gastrocnemius muscles (mgcm). as a surrogate maker of spasticity, h-reflex and compound motor action potential (cmap) of the tibial nerve at mgcm will be recorded pre, during, and post vibration. in investigation i-2, subjects will undergo focal muscle vibration with 0.1, 0.3, 0.5 mm amplitude at mgcm. h-reflex and cmap of the tibial nerve at mgcm will be recorded pre, during, and post vibration. in investigation ii, subjects will undergo focal muscle vibration with predetermined parameters by the investigation i at mgcm. h-reflex and cmap of the tibial nerve and motor evoked potential at mgcm will be recorded pre, during, and post vibration.


Eligibility criteria:
inclusion criteria: * healthy volunteer exclusion criteria: * unstable medical conditions * history of epilepsy * history of drug abuse

Keywords: monosynaptic reflex h-reflex
evaluation of obstetrical and neonatal complications in hereditary haemorrhagic telangiectasia (hht)

Conditions: Osler Rendu Disease; Hereditary Hemorrhagic Telangiectasia

Summary: hereditary haemorrhagic telangiectasia (hht) is a rare inherited genetic disease of autosomal dominant inheritance with a prevalence of about 1/5000. it is manifested by haemorrhage, mucocutaneous telangiectasia and visceral arteriovenous malformations (avms) (lung, liver and nervous system). severe complications during pregnancy in hht are rare but considered high risk. intracranial or pulmonary haemorrhage, stroke and heart failure have been reported in some women with hht during pregnancy. these complications occur most often in the second and third trimesters when maternal physiological changes such as peripheral vasodilatation and increased cardiac output are at their peak. previous retrospective studies were conducted with numbers ranging from 40 to 97 patients and highlighted the importance of early screening of complications and specific management. the aim of this study is to describe, on a larger number of patients, the obstetric and neonatal complications in patients with hht and followed in the french reference center for hht.


Eligibility criteria:
inclusion criteria: * women ≥ 18 years. * patients monitored for clinically confirmed hereditary haemorrhagic telangiectasia (presence of at least three curaçao criteria) and / or with molecular biology confirmation. * patients with at least 1 full term pregnancy between 1960 and 2018. * received information and no opposition to participate in the study. exclusion criteria: * no full term pregnancies. * refusal to participate in the study.
tissue elastography assessement and cuteous and cubcutaneous thickness measurement following manual lymph drainage in legs with lymphedema

Conditions: Lymphedema; Lower Limb Lymphedema

Summary: tissue elastography assessement and cuteous and cubcutaneous thickness measurement following manual lymph drainage in legs with lymphedema hence the importance of evaluating the impact of an intensive five-day decongestive treatment on lymphedema in terms of cutaneous flexibility and edema regression. patients who are undergoing intensive decongestive treatment for four or five days in the department perform an ultrasound check/examiantion on the first day. during this echography, in 5 usual measurement points are made an ultrasound image recording (for measurement of cutaneous and subcutaneous thicknesses) and an elastography sequence (an instantaneous measurement). the study hypothesis is to note that intensive decongestive treatment has an impact on tissues flexibility and cutaneous and subcutaneous thickness. no many authors discussed this suject, hence the interest of this study. all the data collected and the results obtained will serve for further studies.


Eligibility criteria:
inclusion criteria: * major patients with unilateral or bilateral lymphedema of the lower limb (s), stage ii or iii, of primary or secondary origin * major patients with admitted for the realization of an intensive decongestive treatment (tdi) of three to five days in the lymphology unit of the saint eloi hospital, of montpellier uhc. exclusion criteria: * patients with different lymphedema localisation than the lower limbs * patient with amputated * patient not consenting or included in another clinical research study.

Keywords: skin suppleness elastography lymphedema manual lymphatic drainage
a study to evaluate axatilimab versus best available therapy in participants with chronic graft versus host disease after at least 2 prior lines of systemic therapy

Conditions: Chronic Graft-versus-host-disease

Summary: this study will be conducted to compare axatilimab versus best available therapy in participants with chronic graft versus host disease after at least 2 prior lines of systemic therapy.


Eligibility criteria:
inclusion criteria: * age ≥ 12 years at the time of signing the icf. * active, moderate to severe cgvhd, requiring systemic immune suppression. * participants with refractory or recurrent cgvhd who have received at least 2 lines of systemic therapy, including corticosteroids and ruxolitinib. * concomitant use of systemic corticosteroids is allowed. participants on systemic corticosteroids must be on a stable dose of corticosteroids for at least 2 weeks prior to c1d1. topical and inhaled corticosteroid agents are allowed. * participants must accept to be treated with one of the following bat options on c1d1: cni (cyclosporine or tacrolimus), ecp, mmf, an mtor inhibitor (everolimus or sirolimus), rituximab, pentostatin, proteasome inhibitors, imatinib, or ibrutinib. * history of allo-hct from any donor hla type (related or unrelated donor with any degree of hla matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible. exclusion criteria: * receipt of more than 1 prior allo-hct. prior autologous hct is allowed. * evidence of relapse of hematologic disease or treatment for relapse after the allo-sct was performed, including dli for the treatment of molecular relapse. note: participants who have received a scheduled dli as part of their transplant procedure and not for management of malignancy relapse are eligible. * systemic treatment with cnis or mtor inhibitors started within 2 weeks prior to c1d1. * severe renal impairment, that is, estimated creatinine clearance \< 30 ml/min measured or calculated by cockcroft-gault equation in adults and schwartz formula in pediatric participants, or end-stage renal disease on dialysis. * impaired liver function, defined as total bilirubin \> 1.5 × uln and/or alt and ast \> 3 × uln in participants with no evidence of liver cgvhd. * history of acute or chronic pancreatitis. * active, symptomatic myositis. * pregnant or breastfeeding. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: cgvhd
the association between physical sensations and thinking styles

Conditions: Panic Disorder

Summary: the aim of the study is to examine panic-related associations and interpretations in the context of panic disorder and its treatment. while theoretical accounts of panic disorder suggest a central role of such associations and interpretations in the onset and maintenance of the disorder, research to date in fact leaves many questions about the nature of these dysfunctional cognitions and their potential role unanswered. patients with panic disorder and a control group of patients with other anxiety disorders will complete measures of panic-relevant associations and interpretation bias. the patients with panic disorder will be randomized to receive either cognitive behaviour therapy (cbt) or a waiting list condition (to be followed by cbt after completion of the study procedures). the anxious control group will also receive cbt. panic-relevant associations and interpretations will be measured twice, i.e., pre and post cbt/waitlist. furthermore, relevant symptom measures and physiological and biological markers will be assessed and responses to a hyperventilation challenge. the study aims to further advance our understanding of cognitions in the etiology and maintenance of panic disorder, and inform future treatment optimisation.

the main purpose of the present study is to look at relationships and changes over time but not to compare treatment outcomes (i.e. it is not an efficacy trial). the associations and interpretation measures are listed as primary outcomes because these are the measures of main interest.

Eligibility criteria:
inclusion criteria: * aged 18 to 65 * primary dsm-5 anxiety disorder (panic disorder for panic disorder groups, other anxiety disorder for anxious control group) * provided written informed consent * patient is in principle able to take part in the therapy * sufficient knowledge of german language * outpatient (no parallel hospital stay) * medical certificate: medical safety, so that hyperventilation is possible exclusion criteria: * any reason that jeopardises the performance of the therapy * acute suicidality * primary affective disorder (e.g. bipolar i, major depression) * psychotic disorder * parallel psychiatric or psychotherapeutic treatment (acute treatment) * current substance dependence (apart from nicotine dependence) * serious medical disorders/ findings * other primary treatment diagnosis * intellectual impairment (estimated during screening) * adhd (estimated during screening) * personality disorders

Keywords: cognitive biases associations interpretations physiological and biological markers
refitting daily disposable contact lens wearers with dry eye disease with a different daily disposable lens type

Conditions: Dry Eye

Summary: the purpose of this study is to refit habitual wearers of daily disposable contact lenses who currently experience symptoms of dry eye and discomfort during lens wear with a different type of daily disposable contact lens. ocular signs and symptoms of dry eye will be assessed following the guidelines outlined by the tear film and ocular surface society (tfos) in the dry eye workshop ii (dews ii). the performance of the habitual contact lenses and the study lenses will be determined using different optometric assessments. study lenses will be worn for one month following a daily disposable wear schedule.


Eligibility criteria:
inclusion criteria: 1. is at least 17 years of age and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. is willing and able to follow instructions and maintain the appointment schedule; 4. as per tfos dews ii, have dry eye symptoms (without cl wear) as determined by an osdi score of ≥13 and at least one of the following: 1. tear osmolarity ≥ 308mosm/l or interocular difference \>8 mosm/l 2. non-invasive tear breakup time of \< 10 seconds in at least one eye 3. more than 5 spots of corneal staining or \> 9 conjunctival spots in at least one eye 5. reports dryness while wearing dd cls with cldeq-8 score ≥ 12 and ≤ 203 6. habitually wears soft spherical dd cls with a power between +6.00d and -10.00d 7. manifest spectacle cyl ≤1.00dc in either eye 8. bcva ≤0.20 log mar each eye with habitual \& dt1 9. acceptable fit with habitual \& dt1 10. willing to wear dt1 cls at least 3 days per week and 6 hours per day throughout the study exclusion criteria: 1. is participating in any concurrent clinical or research study; 2. has any known active\* ocular disease and/or infection; 3. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 6. is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report); 7. is aphakic; 8. has undergone refractive error surgery; 9. has taken part in another clinical research study within the last 14 days; 10. current habitual wearer of dt1 11. any ocular and/or systemic conditions or concomitant medication to contraindicate contact lens wear or be expected to interfere with the primary outcome variables. * for the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
a study to go back into records and observe how people with metastatic renal cell carcinoma (mrcc) who received a medicine called sunitinib responded to this medicine.

Conditions: Carcinoma, Renal Cell; Clear-cell Metastatic Renal Cell Carcinoma

Summary: the purpose of this study is to understand how patients with mrcc respond to the study medicine (called sunitinib) when they receive it as the first line of treatment after finding out the cause for the disease. this study will look into how different and how well groups of people with high chances of developing the disease respond to the study medicine. all data for this study will be anonymously extracted from data already entered in rcc registry which is owned by turkish oncology group association (togd). this study will pull out records from the registry between 01-mar-2019 and 30-oct-2022 that belongs to people: * who are turkish citizens * who are older than 18 years * who were found out to have mrcc * who received sunitinib as the first line treatment after finding out the cause for the disease this study will look at the responses, experiences and how long the patients use the study medicine sunitinib.

this study is designed as a local, non-interventional, retrospective, registry-based study to observe treatment response in patients with metastatic renal cell carcinoma with sunitinib first-line therapy based on data extracted and analyzed from the rcc registry. the annual disease burden in contributing centers to rcc registry is approximately 100 patient/center, the treatment of an average of 250 patients per year is continued in the centers. therefore, it is estimated that information of approximately 400 eligible patients who were registered in rcc registry from 2019 to 2022 will be included in the analysis. rcc registry will be used as the sole data source for this study. for this purpose, no case report forms (crfs) or data collection tools (dcts) will be utilized, but the rcc registry database will be used directly. eligible patients' data will be anonymized and extracted for analysis by the registry owner, for this study.

Eligibility criteria:
inclusion criteria: * being a turkish citizen. * being older than 18 years-old. * being clinically diagnosed with mrcc and treated. * being treated with sunitinib in first line exclusion criteria: * patients whose treatment was initiated but excluded from follow-up for any reason.

Keywords: mrcc metastatic renal cell carcinoma clear-cell metastatic renal cell carcinoma
study of v117957 in overactive bladder syndrome

Conditions: Overactive Bladder Syndrome

Summary: the purpose of this study is to evaluate the safety, tolerability and efficacy of v117957 in subjects with overactive bladder syndrome, compared to placebo.


Eligibility criteria:
key inclusion criteria include: 1. female, age ≥18-70 years and capable of voiding independently. able to comply with acceptable methods of contraception. 2. has symptoms of overactive bladder including (oab) urinary urgency and urinary frequency with incontinence for ≥3 months. 3. willing to modify current oab treatment regimen. key exclusion criteria include: 1. significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor. 2. urinary tract infection (uti) within past 30 days, or history of recurrent uti. 3. hematuria associated with bladder malignancy or other significant pathology. 4. had surgical procedure that affected bladder function. 5. received intravesical therapy within past 12 months or had bladder hydrodistention within past 6 months. 6. grade iii/iv pelvic organ prolapse with/without cystocele or urethral diverticulum. 7. clinically significant kidney disease or nephrolithiasis. other protocol-specific inclusion and exclusion criteria may apply.
action observation therapy with and without acoustic stimulation in post stroke gait and balance

Conditions: Stroke

Summary: stroke causes the interruption of blood flow towards the brain cells which results in cell death and lead to variety of disorders including deficits in balance and gait. it is well known that it is causing death and disability .the incidence of stroke is increasing in low-income countries because of not using evidence-based practice in health-related conditions in these countries. action observation training is one of the new developing rehabilitation technique that targets motor learning by the activation of mirror neurons and is the most important approach that targets the motor and functional recovery in stroke patients. a new treatment approach i .e action observation therapy, in which the movements are observed by the patient to provide visual stimulus, then patients are asked to perform those movements. a new approach acoustic stimulation is introduced for improving gait and balance in post stroke patients in which individual patient cadence is used to adjust the beats of sound so that auditory stimulation causes recovery.

stroke is a medical condition which causes the cessation of blood flow to the brain cells and results in cell death. it is a leading cause of death and disability. geographical variations play a huge role in the burden for stroke. a stroke survivor experiences a range of symptoms that make it harder for them to carry out regular tasks and raise their risk of falling while walking .the effects of action observation therapy with acoustic stimulation on balance in stroke patients have not been explicitly covered in recent studies. the study intends to evaluate the effectiveness of treatments with evidence for post-stroke balance and gait.

Eligibility criteria:
inclusion criteria: * age 40-60 years * both male and female * any type of stroke * walking few steps \[5 or more\] . * berg balance score above 21 * ability to follow the study instructions-mini mental state examination (mmse ) score \>24 exclusion criteria: * patients diagnosed with other neurological diseases * tumors or neoplasms * cardiopulmonary diseases * patient with impaired cognition * visual and auditory impairments
bioequivalency study of terbinafine tablets under fasting conditions

Conditions: Onychomycosis

Summary: the objective of this study was the bioequivalence of a roxane laboratories' terbinafine tablets, 250 mg, to lamisil® tablets, 250 mg (novartis pharmaceutical corporation.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to terbinafine or any comparable or similar product.
study evaluating the effect of food on the bioavailability of pn400 components

Conditions: Arthritis

Summary: we will evaluate the effect of food on the bioavailability of the components of pn400


Eligibility criteria:
inclusion criteria: * healthy male or non-pregnant female subjects between 18-55 years old as well as other standard inclusion criteria for a study of this nature. exclusion criteria: * standard exclusion criteria for a study of this nature.